Evaluation of the performance of CareStart™ Malaria Pf/Pv Combo and Paracheck Pf® tests for the diagnosis of malaria in Wondo Genet, southern Ethiopia

ObjectiveTo evaluate the diagnostic performance of CareStart™ Malaria Pf/Pv Combo test relative to microscopy for the diagnosis of falciparum and vivax malaria in Ethiopia.Methods668 febrile patients visiting two health centers in Wondo Genet, southern Ethiopia, involved in this study in 2008. Giemsa-stained thin and thick blood smears were prepared and microscopically examined under a 100× oil immersion microscope objective for Plasmodium species identification and determination of parasitaemia, respectively. CareStart™ Malaria Pf/Pv Combo test and Paracheck Pf® test were performed as per the manufacturers’ instruction.FindingsThe diagnostic validity of CareStart™ Malaria Pf/Pv Combo test for the diagnosis of Plasmodium falciparum were very good with sensitivity of 99.4%, specificity of 98%, positive predictive value of 94.4% and negative predictive value of 99.8%. Sensitivity, specificity, positive predictive value and negative predictive value of the test for the diagnosis of P. vivax were 99.4%, 98.2%, 94.5% and 99.8%, respectively. The diagnostic performance of CareStart™ Malaria Pf/Pv Combo test is comparable to that of Paracheck Pf® test for the diagnosis of P. falciparum (sensitivity 99.4%, specificity 98.2%).ConclusionAlthough CareStart™ Malaria Pf/Pv Combo test and Paracheck Pf® test have comparable diagnostic performance for the diagnosis of P. falciparum, CareStart™ Malaria Pf/Pv Combo test has the added advantage of diagnosing P. vivax. Hence, it is preferable to use CareStart™ Malaria Pf/Pv Combo test for the diagnosis of malaria in areas where microscopy is not accessible and where malaria due to P. falciparum and P. vivax are co-endemic as in Ethiopia.